Job title: Literature review advisor (Astrazeneca)

Roles and Responsibilities

Accountabilities:

• Literature Review Procedures

• Ensure the quality and comprehensiveness of literature searches, including the use of AstraZeneca databases.

• Conduct reconciliations ensuring the accuracy of pharmacovigilance data that is transferred and received.

• Oversee the identification, collection, and analysis of relevant scientific publications, clinical studies, and regulatory reports.

• Keep up to date with industry developments, particularly automation and technology changes, to ensure AstraZeneca leads the way in conducting literature searches.

• Collaboration & Cross Functional Support

• Collaborate with cross-functional teams (Marketing Company collaborators, R&D, regulatory, medical affairs, clinical operations) to provide literature-based insights that inform drug development and regulatory strategies.

• Work closely with subject matter experts to develop clear, concise, and scientifically sound literature materials, summaries, and reports.

• Collaborate with external collaborators and/or academic institutions on literature review-related tasks.

• Regulatory & Compliance Adherence

• Actively contribute to maintaining the core components of Good Pharmacovigilance Practice by contributing to all safety-related processes and brand activities within countries of remit and being audit and inspection ready.

• Support external service providers to meet company and local regulatory PV requirements.

• Complete all required patient safety trainings in adherence to internal processes and external regulations, obtaining access to relevant systems such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate.

• Maintain current and in-depth knowledge of:

• Global and local procedural and guidance documents.

• Marketed status of products in the local country and reference documents (i.e., Core Data Sheet).

• Conditions, obligations, and other commitments relating to product safety or the safe use of AstraZeneca products.

• Essential Skills/Experience:

  • Pharmacovigilance knowledge excellence

  • Good Pharmacovigilance Practice

  • Knowledge of health authority’s regulations

  • Cross functional collaborative approach

  • Effective and lateral thinking

  • Problem solving

  • Vendor management

  • Excellent attention to detail

  • Excellent written and verbal communication skills

  Desirable Skills/Experience:

  • Influencing and Conflict Resolution skills

  • Medical knowledge in company Therapeutic Areas

  • Project management

  • Successful participation in above-market projects

  • Audit & Inspection experience